1. Field of the Invention
The present invention relates to a device for collecting fluids during pelvic procedures such as obstetric, gynecologic, proctologic or urologic procedures. More particularly, the invention relates to a molded disposable plastic tray having structure for collecting fluids and irrigating a surgical site.
2. State of the Art
During vaginal delivery and other types of pelvic procedures it is necessary to collect and drain fluids (and particles entrained in the fluids) which flow from pelvic tracts. The art discloses several devices for achieving this purpose.
U.S. Pat. No. 3,386,444 to Brenner et al. discloses a surgical drain bag and support for use in urological surgery. The drain bag has four flexible side walls, is shaped like an inverted pyramid, and is provided with a drain in a lower portion. The support includes a number of rods which are attached to the end of an examination table and which suspend the bag in a curtain-like manner. The bag also has a flap which rests against the practitioner's chest and acts as a splash guard. This drain bag is a vast improvement over the previously used drain drawers which impeded physician access to the surgical site. Nevertheless, it is cumbersome to install and relatively expensive to manufacture.
U.S. Pat. No. 4,007,741 to Waldrop et al. discloses a transurethral resection apron system which is similar in concept to the drain bag described above. The apron is somewhat simpler to mount, however. It is provided with four corner ties, two of which are tied to uprights on a urological table, and the other two of which are tied to each other behind the surgeon's neck. While this apron offers some advantages over the drain bag, it is still cumbersome to use and relatively expensive to manufacture. Moreover, the attachment to the surgeon's neck inhibits the surgeon and interferes with the surgical procedure.
U.S. Pat. Nos. 4,076,017, 4,105,019, and 4,149,537 to Haswell disclose various embodiments of a postpartum fluid loss receptacle. The receptacle is formed from a substantially rectangular sheet which is folded along its longitudinal axis such that one edge is folded upon itself and sealed to form a pouch. The open end of the sheet is positioned under the patient's buttocks and is thereby supported. The pouch may hang freely from the examination table, or may be supported in a bucket. While the receptacle is relatively inexpensive to manufacture and relatively easy to use, the pliant sheet material does not readily locate the pocket in a convenient manner. It is easy for the pocket to fill and spill over, or to be mispositioned.
U.S. Pat. No. 5,287,860 to Owens discloses a birthing drape. The drape has the geometry of an inverted top hat, with a distal flap and two proximal stirrups. The distal flap is positioned under the patient's buttocks and the stirrups are attached to the patient's ankles. While the drape has some advantages, it is relatively expensive to manufacture and the ankle support stirrups may result in instability of the drape and discomfort for the patient.
U.S. Pat. No. 5,454,797 to Haswell discloses a combined pelvic tray, work station, and fluid collection device. The tray is a rigid sheet of plastic or stainless steel having a first portion which is positioned under the patient's buttocks and a second portion which has a fluid receiving well, receptacles for solutions, instruments, and swabs. A raised fluid dam or dike separates the first and second portions and prevents fluids from flowing under the patient's buttocks. While the rigid plastic tray is easy to use and relatively inexpensive to manufacture, the dam is not completely effective, and the location of the proximal portion of the tray can obscure the surgical site. More specifically, the dam may simply direct the flow of fluids off the side of the tray onto the floor; and the location of the proximal portion of the tray prevents access to the surgical site from below the horizontal plane. In addition, the fluid receiving well is relatively small and is likely to fill quickly.
During vaginal deliveries, it is common to perform an episiotomy. This procedure releases relatively large quantities of blood which must be collected. The above-described devices are more or less successful in collecting blood during an episiotomy procedure. In addition to the need to collect blood during the episiotomy procedure, the flow of blood obscures the surgical site and it is necessary to irrigate the surgical site. The prior art of fluid collection devices does not address this need for irrigation during episiotomy procedures.
The parent application hereto discloses a collection tray for use in pelvic procedures which includes a single piece molded plastic tray having a planar portion, a basin portion, and a live hinge therebetween. The basin portion is preferably provided with a central drain which is adapted to be coupled to a vacuum line. The basin portion is preferably provided with one or more clip structures for holding an irrigation fluid tube so that irrigation fluid may be easily directed toward the site of the procedure. The tray is preferably manufactured by vacuum forming techniques and the outer edge of the basin portion is preferably rolled down to provide a smooth edge and enhanced structural support. A kit containing the tray includes a fluid collection system and an irrigation system having an articulatable nozzle.
Since the filing of the parent application, several improvements have been conceived regarding the central drain, the clip structures, the articulatable nozzle, as well as other aspects of the tray.